Production Scientist

Overview

We are seeking a Production Scientist for our Manufacturing Department in Warren. The Production Scientist will provide day-to-day operations support in a cGMP manufacturing environment for the production of BeadChip and NGS products including formulation of bead intermediates, bulk reagents,and filled vials. If you are interested in helping to save patient lives, this may be the role for you!  

This position is not eligible for sponsorship for work authorization. Therefore, if you will requires sponsorship from us for work authorization now or in the future, we cannot consider your application at this time. 

Responsibilities

Key Accountabilities:

• Perform the following activities in a quality focused cGMP manufacturing environment:
• BeadChip carrier assembly - involves manual and automated equipment processes.
• Formulate custom bulk reagents - involves working with pipettes and balances.
• Bulk and fill reagent manufacturing.
• Weighing, diluting, measuring and verifying chemicals for in-process solutions.
• Packaging of carrier and reagent boxes.
• Ensure materials and equipment are available in inventory for production as required.
• Follow manufacturing schedule. Report issues and concerns to management.
• Perform equipment setup, operation, re-supply, documentation, cleaning, minor equipment adjustments and minor preventative maintenance tasks to meet standards for safety, quality and efficiency.
• Follow GMP documents (e.g., SOPs, Work Instructions, Manufacturing Records) with strict adherence to safety and compliance.
• Create legible written records within batch records/forms.
• Write, revise and update manufacturing documentation.
• Maintain a clean and organized working lab environment.
• Responsible for training on all procedures assigned. Ensure all training is up to date and appropriately documented.
• The ability to be cross trained to assist in other production areas /departments as needed.
• Follows OSHA safety regulations for bloodborne pathogens.

Qualifications

Minimum Knowledge & Experience required for the position:

• Bachelors Degree in a science related field.
• Preferred cGMP manufacturing experience and/or training.
• Basic knowledge of MS Office and software systems used in product support.
• May be required to work irregular hours and days necessary to meet production schedules.
• Overtime may be required which may include holidays and weekends.